Smartphone app to improve psychological wellbeing in Crohn's disease patients
Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
This study is testing a smartphone app to see if it can help people with Crohn's disease feel less stressed, tired, and in pain while improving their overall wellbeing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Soroka University Medical Center Academic / other |
| Locations | 4 sites (Beersheba and 3 other locations) |
| Trial ID | NCT06221254 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the COBMINDEX application, designed to reduce psychological stress, fatigue, and pain in patients with Crohn's disease. Two groups of 200 patients will be randomly assigned to either a human therapist or a digital therapist using the app for a 3-month initial period, followed by 9 months of app usage for both groups. Daily assessments will track stress, pain, fatigue, and overall wellbeing, alongside evaluations of medical, psychological, and immunological status. The goal is to enhance quality of life and coping skills for patients living with Crohn's disease.
Who should consider this trial
Good fit: Ideal candidates are Hebrew-speaking adults aged 18-75 with a confirmed diagnosis of Crohn's disease who have been stable on medical treatment for at least 3 months.
Not a fit: Patients with ulcerative colitis, significant psychiatric disorders, or those planning surgery for Crohn's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the psychological wellbeing and quality of life for patients with Crohn's disease.
How similar studies have performed: Other studies have shown promise in using digital interventions for psychological support in chronic conditions, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willingness to participate and signed informed consent * Hebrew-speaking * Age 18-75 * Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis * Stable medical treatment for the last 3 months * Any Harvey Bradshaw Index score * Ability to operate a smartphone and cellular application Exclusion Criteria: * Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease * Planned surgery for Crohn's disease * Surgery for Crohn's disease (excluding drainage of perianal abscess) in the last 3 months * Psychiatric disease (schizophrenia, major depression or bipolar disorder) * Alcohol or drug dependency (stable medical use of cannabinoids will be allowed) * Pregnancy or planned pregnancy during study period * Clinically significant comorbidity * Former participation in COBMINDEX trials
Where this trial is running
Beersheba and 3 other locations
- Soroka University Medical Center — Beersheba, Israel (Recruiting)
- Rambam Health Care Campus i — Haifa, Israel (Not_yet_recruiting)
- Belinson Medical Center — Petah Tikva, Israel (Not_yet_recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Not_yet_recruiting)
Study contacts
- Study coordinator: Doron Schwartz, MD
- Email: DoronSh@clalit.org.il
- Phone: +972-52-3919044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.